Rheonix, Inc. Receives Fast-Track Grant From FDA To Simplify HIV Testing Company To Complete Automated System For Simultaneous HIV Detection And Confirmation

ITHACA, N.Y. -- Rheonix, Inc., a developer of fully automated molecular testing solutions, has received a Small Business Innovation Research
(SBIR) Phase I Fast-Track grant from the National Institutes of Health
(NIH) to complete the development of a fully automated self-confirming assay that can simultaneously detect HIV/AIDS antibodies and viral RNA in a single specimen. The Rheonix system will simplify HIV testing and eliminate the need for multiple patient visits to a health care provider.

The six-month Phase I award is for $189,646, and it is expected to be followed by an 18-month Phase II award of approximately $1.5 million.

"The funding by NIH further validates the scientific merit of our molecular diagnostics testing platform," said Tony Eisenhut, president of Rheonix. "The success of this program will add a valuable armament to reducing the health burdens of HIV in developing countries and other areas where testing resources are limited."

The global HIV/AIDS epidemic continues to be fueled by the large number of individuals who do not know that they are infected. Governments around the world support various programs to reduce this number by encouraging more frequent testing. However, most current testing procedures require that an initial positive test be confirmed by a second, more sensitive and more specific test. In resource-limited settings, the initial and confirmatory tests often rely upon simple "dipstick-like" tests that lack the sensitivity and specificity of more sophisticated testing. In addition, the second confirmatory test requires a second visit to a health professional that often does not take place.

Rheonix has worked with scientists at New York University (NYU) to develop a unique dual assay that can perform both the initial test and the confirmatory test simultaneously on the same specimen. Under the terms of the grant, Rheonix will continue to collaborate with NYU as the complex bench-top assay is converted to the Rheonix fully automated molecular detection system.

Richard Montagna, Ph.D., FACB, Rheonix senior vice president for scientific and clinical affairs, served as the principal investigator on the grant. "The Rheonix dual-assay system will be the first of its kind in the world able to simultaneously detect the presence of HIV antibodies and confirm the presence of HIV viral RNA in a single test specimen," Montagna said. "By automating the entire process in a small, portable device, resource-limited regions will have their first-ever opportunity to perform simultaneous serological testing and molecular confirmation for HIV."

The assay will be performed on the Rheonix Chemistry and Reagent Device(R), or CARD(R). Once a raw sample is placed on the Rheonix CARD, the automated platform runs with no user intervention through the process of sample extraction, purification, amplification and detection. This eliminates the need for multiple pieces of existing equipment, helping to make the testing process quicker, more efficient, less expensive and less likely to result in human error.

The SBIR Phase I/II fast-track funding program was created by NIH to expedite funding decisions for Phase II efforts on scientifically meritorious applications that NIH believes to have a high potential for commercial success. By allowing a single application to be peer-reviewed for both the Phase I and Phase II portions of proposed development efforts, the normal funding gap between Phase I and Phase II can be virtually eliminated, thus allowing expedited progress toward commercialization to proceed uninterrupted.

For more information, please visit www.rheonix.com.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical and translational medical research, and is investigating the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

About Rheonix, Inc.: Rheonix Inc. is committed to improving standards of care by making molecular diagnostics available to more people, in more places, more often. Rheonix, through experienced leadership and creative vision, has developed the EncompassMDx(tm) platform, a highly customizable technology with unmatched versatility and affordability. The platform performs fully automated, complex molecular assays in an easy-to-use and economical format on the Rheonix CARD(R) cartridge. With both the Rheonix CARD and EncompassMDx family of products, Rheonix is well-positioned to penetrate key molecular diagnostic market sectors, from reference labs through point-of-care and everywhere in between. For more information, visit www.rheonix.com.

(Disclaimer: Any opinions, findings and conclusions or recommendations expressed in this release are those of Rheonix and do not necessarily reflect the views of the National Institutes of Health.)